This is a cross sectional Phase 4, multicenter, study of AVONEX® and JUMTAB® to determine the frequency of IFN induced Neutralizing Antibodies (Nabs). A secondary component is the long term retrospective observational evaluation conducted to measure efficacy, adherence to therapy, tolerability, and safety in subjects with relapsing MS related to antibody status and treatment.

Percent of patients with interferon induced neutralizing antibodies measured in a luciferase test [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate and duration of corticosteroid use for relapse [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Need and duration of hospitalization for relapse [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Genetic profile of patients with relation to their predisposition to Nab development [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

The interferon activity will be tested by neopterin protein activation (level before IFNbeta1a IM injection and 48 hours after the injection) [ Time Frame: twice measured: - Day 1 before IFN injection - 48-72hours after the IFN injection ] [ Designated as safety issue: No ]

Genetic profile of population with relation to predisposition to Nab generation [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Rate/ duration of corticosteroid use for relapse [ Time Frame: measured up to 3 years prior to enrollment @ Day 1 ] [ Designated as safety issue: No ]

Need/ duration of hospitalization for relapse [ Time Frame: measured up to 3 years prior to enrollment @ Day 1 ] [ Designated as safety issue: No ]

Genetic profile of patients with relation to the predisposition to Nab development [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Interferon activity will be tested by neopterin protein activation before and after injection [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]

The primary objective of this study is to evaluate the frequency of neutralizing antibodies in patients treated with IFN beta 1a IM (Avonex) and IFN beta 1a IM biosimilar formulation (Jumtab).

Secondary objectives:

Evaluate the effect of Nabs on the severity of the relapses on each treatment group, measured by:

The need and duration of steroid courses

The need and duration for hospitalization.

To evaluate the safety and tolerability of the IFN beta 1a IM treatments [Avonex and Jumtab].

To identify the genetic profile of the patients with relation to the predisposition to Nab development (HLA DR4 (in particular HLADRB1* 0401 and 0408) and DR16 (in particular HLADRB1* 1601)

At selected sites: To evaluate the influence of the interferon and the Nabs on the activation of neopterin

Eligibility

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of selection:

No limitation of age, EDSS or other disease parameters will be applied.

Subject with MS

Subjects treated with IFN beta 1a IM (Avonex) or the biosimilar formulation of IFN beta 1a IM (Jumtab) in line with the local prescription information

The IFN beta 1a IM (Avonex or Jumtab) treatment should be the first disease modifying treatment

The subject should be treated with the same drug for at least 18 months and up to a maximum of 3 years

Exclusion Criteria:

Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of selection:

No informed consent

Patients with combination therapy (IFN + immunosuppressive therapy)

Patients pretreated with immunosuppressive therapy

Treatment with any investigational product, including investigational symptomatic therapies for MS (e.g., 4Aminopyridine) and investigational therapies for NonMS indications, during the review period.

NOTE: subjects may receive investigational symptomatic therapies for MS at any time prior to evaluation period.

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556685